BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT VR RF

    MDR report key: 8580851 · Received May 5, 2019

    Report

    Report Number
    2017865-2019-06504
    Event Type
    Malfunction
    Date Received
    May 5, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 5, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05414734501941
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND AN EVENT OF CHARGE TIME LIMIT REACHED VIA REVIEW OF THE DEVICE IMAGE. THE CAUSE OF THE CHARGE TIME LIMIT REACHED WAS UNKNOWN.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374180 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1207-36 0002131814 05414734501941

    Patients

    Seq Age Sex Outcome Treatment
    1